FDA.reportPublic FDA data

Livongo Welcome Kit

Primary DI
00853553005257
Brand
Livongo Welcome Kit
Company
LIVONGO HEALTH, INC
Model
Livongo G1.5
Catalog number
KIT00441
Device description
Livongo Welcome Kit G1.5 with BG200, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile Lancets, 1 box of Livongo Control Solution high/low, 1 Livongo Lancing device, 1 Livongo Carrying case, 1 charger, 1 charger cable, 1 Instructions for Use (English), 1 Instructions for Use (Spanish), 1 User Guide (English), 1 User Guide (Spanish)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133584000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133584000IN TOUCH BLOOD GLUCOSE MONITORING SYSTEMEoshealth, Inc.2014-09-08CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853553005257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853553005257008535530052578535530052570853553005257

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure0 KiloPascal75 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.945.4355membersupport@livongo.com

Regulatory Flags#

DUNS number
829984561
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853553005615Teladoc Health, IncWM1500 Modem ModuleOFG063082023-08-25
00810079240265Livongo Health, Inc. by Teladoc Health, Inc. BG300 - LVL, CH & MXKIT0000042025-10-14
00810079240364Livongo Health, Inc. by Teladoc Health, Inc.BG300 WK - Bridge CH or MYKIT0000262025-10-14
00810079240524Livongo Health, Inc. by Teladoc Health, Inc. BG300 - RRD RKKIT0000372025-10-14
00810079240142LivongoBG300 - MXOFG0000022025-09-25
00853553005028In Touch Glucose Control SolutionsIn TouchOFG001402016-09-24
00853553005035In Touch Blood Glucose MeterBG200FG001632016-09-24
00853553005059Inb Touch Lancing DeviceIn TouchOFG001412016-09-24
00853553005066In Touch Sterile LancetsIn TouchOFG001422016-09-24
00853553005097In Touch Welcome KitIn TouchKIT001452016-09-24
00853553005103In Touch Refill KitIn TouchKIT001472016-09-24
00853553005110In Touch Blood Glucose Test StripsIn TouchOFG001542016-09-24
00853553005141In Touch Lancing DeviceIn TouchOFG001562016-09-24
00853553005158In Touch Glucose Control SolutionIn TouchOFG001552016-09-24
00853553005189In Touch Lancing DeviceIn TouchOFG002042016-09-24
00810079260027Teladoc Health, IncScale, 4G Cellular Weight Management, Bridge BrandKIT108142023-08-25
00810079260058Teladoc Health, IncWM1500 Scale, BG95-M2OFG0000132023-08-25
00853553005646Teladoc Health, IncWelcome Kit, 4G Cellular Body Scale WM1500KIT063072023-08-25
00853553005738Livongo Test Strips - MexicoLivongoOFG103532022-09-20
00853553005752Livongo WM1500 Welcome KitWM1500 Welcome KitKIT108142022-04-22

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